Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine)
FDA premarket approval P160042/S029 · decided 2025-12-22
Approval details
- PMA number
- P160042
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Prollenium Medical Technologies, Inc.
- Date received
- 2025-11-28
- Decision date
- 2025-12-22
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Aurora
- Statement
- approval for modifications to cleanroom layout in a secondary manufacturing facility
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